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CR 12-X DIGITIZER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131408
510(k) Type
Special
Applicant
AGFA HEALTHCARE N.V.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/2013
Days to Decision
106 days
Submission Type
Summary

CR 12-X DIGITIZER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131408
510(k) Type
Special
Applicant
AGFA HEALTHCARE N.V.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/2013
Days to Decision
106 days
Submission Type
Summary